Specifically, the tubes or pipes used in the biopharmaceutical field are flexible or highly flexible pipes which are used to convey various biopharmaceutical substances, most often with the aseptic precautions required.
In biopharmaceutical applications, this type of flexible pipe allows the circulation, passage, and communication of a fluid such as a biopharmaceutical fluid, and can either be connected to a similar flexible pipe or to a vessel or container which may be flexible or rigid.
The vessel or container in question may in this case be a container for storing and/or processing content such as a biopharmaceutical product. Such a container is in this case understood to mean a rigid or semi-rigid reusable container or a flexible disposable container such as a bag or possibly even a filter cartridge.
This bag may be one of the substantially thin “2D” bags, such as those marketed by Sartorius Stedim Biotech under the brand Flexboy®, having a typical volume of between 50 ml and 50 liters. This flexible bag may also be a “3D” bag, such as those marketed by Sartorius Stedim Biotech under the brand Flexel®, having a larger volume and a substantial size in all three dimensions. Note that a pipe such as the pipe of the invention can be placed between two bags or a larger number of bags.
A pipe of the invention, usually of circular cross-section, is typically made of a plastic such as silicone, thermoplastic elastomers (TPE), or PVC, although this list is not limiting. It has a certain general stability, and simultaneously both a certain overall flexibility and a certain local flexibility, which allows crimping the pipe or substantially deforming it radially when sufficient force is applied.
In a typical embodiment, for example, the pipe has an outer diameter between 8 mm and 30 mm for example, with the thickness depending on the material, the diameter, and the applications.
In the prior art, in order to couple such a flexible pipe, it is slipped over a tubular nozzle, whereupon a pipe clamp is placed around the pipe and the clamp is then tightened. The tightened clamp thus exerts a radial inward pressure to retain the flexible pipe on the nozzle, on the one hand to ensure a good seal between pipe and nozzle and on the other to prevent the pipe from detaching from the nozzle when pulled.
For such pipe clamps, a plastic clamp can be used for example, of polyamide for example such as Rilsan®. This type of plastic clamp, also sometimes called Serflex®, comprises a system of notches on a strip cooperating with a locking hook arranged in the head, such that the tightening is not reversible. In other words, after the strip is inserted into the head to form a loop, the strip is pulled to reduce the diameter of the loop and tighten the clamp; any return movement is prevented by the engagement of the hook in one of the notches of the strip. After tightening, to prevent the strip from projecting too far beyond the diameter of the clamp loop, the free portion of the strip is cut off close to the head of the clamp. The undetached remaining portion of the strip often has a sharp edge which can cut.
As an alternative to the plastic clamp, a metal clamp can be used which is in the form of a preformed ring having one or two “ears” projecting outward beyond the general shape of the ring of the clamp; this type of clamp is sometimes referred to as an Oetiker® clamp. After placement of the clamp on the pipe to be retained, a tool is used to crimp the ear (or ears) of the clamp which causes a permanent deformation and thus a narrowing of the major diameter of the ring and as a result tightens the clamp on the pipe. This type of clamping with a metal ring is particularly robust and reliable. However, at the point where the ear was crimped by the tool, there may be a burr or roughness which forms a sharp edge that can be damaging.
The metal clamp could also be a crimp-on earless metal clamp.
Whether plastic or metal, once such clamps are installed in biopharmaceutical assemblies, these assemblies may need to be transported or moved and there is therefore a risk of damage by the damaging parts of these clamps to other elements of the biopharmaceutical assembly, particularly the flexible bags or flexible pipes, which can cause a leakage or loss of sterilization that is detrimental to biopharmaceutical applications.
In addition, these clamps are easy to access (and thus can be removed) and do not allow guaranteeing a satisfactory image or aesthetics.
There is therefore a need to propose an improvement intended to at least partially overcome the above drawbacks of the known prior art.